Bipin Patel
RSServe, India
Title: Audits and Inspections - bioavailability and bioequivalence studies
Biography
Biography: Bipin Patel
Abstract
‘Quality-the degree of excellence’ is one of the most important aspect that human strive for, especially when it is related to human life and well being. Quality assurance audits and regulatory inspections are an important and essential part of clinical research with aim to evaluate the quality of the research conducted by sponsors, CROs and other institutions. Quality of clinical research revolves around two main parameters: Rights, safety and well being of subjects; and integrity of the data generated and submitted to regulatory authorities. Because of the steep increase in Bioavailability and Bioequivalence (BABE) centers and studies conducted in India, there is an increase scrutiny by the regulatory authorities across the globe to visit India based BABE centers to confirm quality of study conducted and to verify the integrity of data submitted. The outcomes of these inspections are mixed but sometimes negative with huge implications for sponsors. Although regulatory inspections for BABE studies generally occur after submission of data to regulatory authorities. These can something be unannounced and hence companies routinely runs ‘inspection readiness and ‘mock inspection programs’. The presentation aims to cover following topics: Brief introduction on quality in clinical research; quality control, quality assurance and regulatory inspections; process followed during audits and inspections; audit and inspections finding classifications; findings noted from recent regulatory inspections; and impact of regulatory inspections on BABE studies/centers and sponsors.